Summary: H.R.3995 — 99th Congress (1985-1986)All Information (Except Text)

There is one summary for H.R.3995. Bill summaries are authored by CRS.

Shown Here:
Introduced in House (12/19/1985)

Pharmaceutical Export Amendments of 1986 - Amends the Federal Food, Drug, and Cosmetic Act to permit the export of certain drugs (including biological products) intended for human or animal use even though such drugs have not been approved or licensed for use in the United States.

Directs the Secretary of Health and Human Services to establish and update a two-tiered list of countries with adequate governmental health authorities which in the first tier includes developed regulatory procedures and tests with experienced scientific personnel and in the second tier includes sufficient ability to assure consistency of labeling information. Permits shipments to nonlist countries if differing health conditions there make such shipments desirable, e. g. tropical diseases.

Permits the export of an unapproved drug to a second tier country if such drug is approved for use in any first-tier country and not banned for use in any first-tier country.

Prohibits the export of drugs denied approval on the basis of safety and efficacy or whose manufacture in the United States has been determined to be contrary to U.S. health and safety.

Sets forth other criteria and restrictions on the export of such drugs, including notice requirements on shipments and notice of and opportunity to cure deficiencies in such shipments. Permits the Secretaries of Agriculture and Health and Human Services to prohibit noncomplying shipments and shipments otherwise permitted if either Secretary determines a shipment would present an imminent hazard to the public health of the recipient country.

Requires the Comptroller General to report biennially to the Secretary of Health and Human Services and the Congress on the extent to which drugs unauthorized for a country are being received by such country and the extent to which labeling is consistent.

Directs the Secretary to contract for a study to be submitted to the Congress within five years on the economic and international health impact of this Act.

Includes conditions prevalent in a developing country among the criteria for orphan drugs.